Back to resultsBleeding Time Study With AZD6482, Clopidogrel and ASA
Primary Purpose
Antiplatelet Effect
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
AZD6482
Clopidogrel
ASA
Sponsored by
About this trial
This is an interventional treatment trial for Antiplatelet Effect focused on measuring Antiplatelet
Eligibility Criteria
Inclusion Criteria:
- BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
- Provision of written informed consent
Exclusion Criteria:
- Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.
- Acute illness, surgical procedure or trauma from 2 weeks before pre-entry visit until the first baseline visit or clinically significant abnormalities in clinical chemistry, haematology, urinalysis or supine BP or pulse
- Known impaired glucose tolerance, known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or known or suspected Gilbert's syndrome
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
AZD6482 on top of ASA
Clopidogrel on top of ASA
Outcomes
Primary Outcome Measures
Capillary Bleeding Time (CBT)
Secondary Outcome Measures
Effect on bleeding
Pharmacokinetics
Safety variables (adverse events, blood pressure, pulse, ECG, safety lab)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00853450
Brief Title
Bleeding Time Study With AZD6482, Clopidogrel and ASA
Official Title
A Randomised, Open-label, Single-Centre, Phase I, Crossover Study to Evaluate the Effect of AZD6482, Compared With Clopidogrel, on Bleeding Time in Healthy Volunteers Receiving Low-Dose ASA
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to evaluate the effect of AZD6482 and clopidogrel on bleeding time when taken together with low-dose ASA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antiplatelet Effect
Keywords
Antiplatelet
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AZD6482 on top of ASA
Arm Title
2
Arm Type
Active Comparator
Arm Description
Clopidogrel on top of ASA
Intervention Type
Drug
Intervention Name(s)
AZD6482
Intervention Description
Single intravenous infusion during a maximum of 5 hours
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix®
Intervention Description
Oral doses given once daily during 7 days. 300 mg on day 1 and 75 mg on day 2 to 7.
Intervention Type
Drug
Intervention Name(s)
ASA
Other Intervention Name(s)
Trombyl®
Intervention Description
75 mg orally once daily during 7 days in each treatment arm
Primary Outcome Measure Information:
Title
Capillary Bleeding Time (CBT)
Time Frame
Prior to first dose in each treatment period, on study day 6 and 7 in treatment period A and on study day 7 in treatment period B
Secondary Outcome Measure Information:
Title
Effect on bleeding
Time Frame
Prior to first dose in each treatment period, twice on study day 6 and three times on study day 7 in treatment period A and twice on study day 7 in treatment period B
Title
Pharmacokinetics
Time Frame
Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion
Title
Safety variables (adverse events, blood pressure, pulse, ECG, safety lab)
Time Frame
Repeatedly during the study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
Provision of written informed consent
Exclusion Criteria:
Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.
Acute illness, surgical procedure or trauma from 2 weeks before pre-entry visit until the first baseline visit or clinically significant abnormalities in clinical chemistry, haematology, urinalysis or supine BP or pulse
Known impaired glucose tolerance, known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or known or suspected Gilbert's syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Held
Organizational Affiliation
AstraZeneca Mölndal
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bo Fransson, MD
Organizational Affiliation
AstraZeneca Clinical Pharmacology Unit, Lund
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Lund
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Bleeding Time Study With AZD6482, Clopidogrel and ASA
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